Caphosol Artificial Saliva (32 doses sachet box). 64 x 15… recallZ-2012-2025 · Recordati Rare Diseases Inc. · initiated Jun 11, 2025

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Recordati Rare Diseases Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Out of specification stability test result for the Caphosol B solution from process validation lots

FDA root cause category: Device Design

What the company is doing

Recordati Rare Diseases Inc. notified consignees on about 06/11/2025 via emailed letter. Consignees were instructed to examine inventory for affected lots, discontinue using, dispensing and distributing the affected lots, and promptly return any inventory. Consignees were also instructed to complete and return the Recall Response Form as well as notify consignees if the affected lots were further distributed.

Recall details

Recall number: Z-2012-2025
Status: Open, Classified
Initiated by the company: Jun 11, 2025
Posted by the FDA: Jun 23, 2025
Recalling firm: Recordati Rare Diseases Inc.
Quantity: 3,754 boxes (120,128 doses)
Product code: LFD
FDA submissions: K234015
Distribution: Worldwide - US Nationwide distribution in the states of GA, OH, TN, TX, VA and the countries of Germany, France, Italy, Portugal, Spain, Sweden, United Kingdom.

Product description

Caphosol Artificial Saliva (32 doses sachet box). 64 x 15 mL sachets aqueous solution (32 sachets Solution A Phosphate, 32 sachets Solution B Calcium)

Code information (models, lots, serial numbers)

UDI-DI: 5060146293129. Lot Numbers: 001U002U, 001U002UA. Expiration 2026-10

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Caphosol® Artifical Saliva 64 x 15 mL sachets aqueous solution
Eusa Pharma (Uk) Limited · Saliva, Artificial
1 recall0 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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